초록 ▼

A vial adapter is described comprising a housing, the housing comprising an expandable chamber to contain a volume, an internal passage in communication with the expandable chamber, at least one opening in communication with the internal passage, and an access member integral with the housing. A hol

A vial adapter is described comprising a housing, the housing comprising an expandable chamber to contain a volume, an internal passage in communication with the expandable chamber, at least one opening in communication with the internal passage, and an access member integral with the housing. A hollow spike comprising a proximal end is integral with the housing and a distal end. The spike comprises a vent lumen open at the distal end and a fluid lumen open at the distal end, the vent lumen is in communication with the internal passage and the fluid lumen is in communication with the access member. A first check valve restricts communication from the expandable chamber to the internal passage, and a second check valve restricts communication from the internal passage to the opening. Methods of reconstituting and/or withdrawing hazardous material using the vial adapter are described.

대표청구항 ▼

What is claimed is: 1. A vial adapter comprising: a housing, the housing comprising an expandable chamber to contain a volume, wherein the expandable chamber transitions from an initial volume to a final volume greater than the initial volume upon containing the volume; an internal passage in commu

What is claimed is: 1. A vial adapter comprising: a housing, the housing comprising an expandable chamber to contain a volume, wherein the expandable chamber transitions from an initial volume to a final volume greater than the initial volume upon containing the volume; an internal passage in communication with the expandable chamber; at least one opening in communication with the internal passage; an access member integral with the housing; a spike comprising a proximal end integral with the housing and a distal end, the spike further comprising a vent lumen open at the distal end and a fluid lumen open at the distal end, the vent lumen in communication with the internal passage and the fluid lumen in communication with the access member; a first check valve restricting communication from the internal passage to the at least one opening; and a second check valve restricting communication from the expandable chamber to the internal passage. 2. The vial adapter according to claim 1, further comprising a skirt portion integral with the housing and at least partially surrounding the spike, the skirt portion having at least one securing member for securing the vial adapter to a sealed vessel such that the spike accesses the interior of the vessel. 3. The vial adapter according to claim 1, further comprising at least one hydrophobic filter. 4. The vial adapter according to claim 3, wherein the at least one hydrophobic filter is in communication with both the vent lumen and the opening. 5. The vial adapter according to claim 3, wherein the at least one hydrophobic filter is in communication with both the vent lumen and the expandable chamber. 6. The vial adapter according to claim 3, wherein the at least one hydrophobic filter is between the vent lumen and the opening. 7. The vial adapter according to claim 3, wherein the at least one hydrophobic filter is between the vent lumen and the expandable chamber. 8. The vial adapter according to claim 1, wherein the expandable chamber is expandable such as to contain at least a portion of a fluid volume equivalent to that introduced through the access member. 9. The vial adapter according to claim 8, wherein the expandable chamber is at ambient pressure in the expanded position. 10. The vial adapter according to claim 8, wherein the expandable chamber is at greater than ambient pressure in an expanded position. 11. The vial adapter according to claim 1, wherein at the first check valve is positioned between the opening and the internal passage. 12. The vial adapter according to claim 1, wherein at the second check valve is positioned between the expandable chamber and the internal passage. 13. The vial adapter according to claim 1, wherein the first and/or second check valve restricts leakage at less than 2 psi. 14. The vial adapter according to claim 1, wherein the access member is a needle-free valve. 15. The vial adapter according to claim 14, wherein the needle-free valve comprises a female opening securable to a male connector such that two-way fluid communication is provided through the access member. 16. The vial adapter according to claim 14, wherein the needle-free valve is self-sealing. 17. The vial adapter according to claim 1, further comprising a needle-free valve connector secured with the access member of the housing. 18. The vial adapter according to claim 1, wherein the spike is plastic. 19. A vial adapter for entering the interior of a drug container fitted with a penetrable closure and for removing material from or adding material to the drug container, the vial adapter comprising: a housing, the housing comprising: a hollow spike proximally extending from the housing and open proximal to the distal end, the spike comprising a fluid lumen having an open end and a vent lumen having an open end; an internal passage providing two-way communication with the interior of the drug container via the vent lumen, an access member providing two-way communication with the interior of the drug container via the fluid lumen, and an opening in one-way fluid communication with the internal passage for maintaining the internal drug container at ambient pressure when removing material from the drug container via the access member and for restricting fluid transfer from the internal passage; and an expandable chamber integral with the housing, the expandable chamber in one-way fluid communication with the internal passage, wherein the expandable chamber transitions from an initial volume to a final volume greater than the initial volume upon containing the volume. 20. The vial adapter according to claim 19, wherein the access member is a needle-free valve. 21. The vial adapter according to claim 20, wherein the needle-free valve comprises a female opening securable to a male connector such that two-way fluid communication is provided through the access member. 22. The vial adapter according to claim 20, wherein the needle-free valve is self-sealing. 23. The vial adapter according to claim 19, further comprising a needle-free valve connector secured with the access member of the housing. 24. The vial adapter according to claim 19, further comprising a skirt portion integral with the housing and at least partially surrounding the spike, the skirt portion having securing members for securing the vial adapter to the drug container such that the spike accesses the interior of the vessel. 25. The vial adapter according to claim 19, wherein the internal passage includes a first check valve positioned between the opening and the internal passage. 26. The vial adapter according to claim 19, wherein the internal passage includes a second check valve positioned between the expandable chamber and the internal passage. 27. The vial adapter according to claim 19, wherein the first and/or second check valve restricts leakage at less than 2 psi. 28. The vial adapter according to claim 19, wherein the check valve is a spiral check valve, ball check valve, duck-bill check valve or swing check valve. 29. The vial adapter according to claim 19, further comprising at least one hydrophobic filter. 30. The vial adapter according to claim 29, wherein the at least one hydrophobic filter is in communication with both the vent lumen and the opening. 31. The vial adapter according to claim 29, wherein the at least one hydrophobic filter is in communication with both the vent lumen and the expandable chamber. 32. The vial adapter according to claim 29, wherein the at least one hydrophobic filter is between the vent lumen and the opening. 33. The vial adapter according to claim 29, wherein the at least one hydrophobic filter is between the vent lumen and the expandable chamber. 34. The vial adapter according to claim 19, wherein the spike is plastic. 35. A vial adapter for a drug container comprising: a housing having an upper section and a lower section in sealed relationship, each upper and lower section having a top and bottom surface; a hollow spike having a proximal end extending from the top surface of the lower housing section forming a flange, the spike further having a distal end extending from the bottom surface of the lower housing, the spike having a fluid lumen parallel with a vent lumen, the fluid lumen and the vent lumen being open at the proximal end of the spike and the fluid lumen and the vent lumen being open proximal to the distal end of the spike; an access member integral with the upper housing section, the access member having a two-way communicable passage through the fluid lumen of the spike; an opening through the upper housing; a filter positioned between the upper and the lower housing sections; an internal passage positioned between the upper and the lower housing sections, the internal passage in fluid communication with the opening and the vent lumen, the internal passage being isolated from the fluid lumen; a first check valve providing one-way fluid communication through the opening into the internal passage; an expandable chamber integral with the housing and in fluid communication with the internal passage of the housing, the expandable chamber having a flexible member secured thereto, wherein the expandable chamber transitions from an initial volume to a final volume greater than the initial volume upon containing the volume; and a second check valve providing one-way communication through the internal passage and into the expandable chamber. 36. The vial adapter according to claim 35, further comprising a skirt member integral with and extending from the bottom face of the lower housing section, the skirt at least partially surrounding the spike. 37. The vial adapter according to claim 36, wherein the skirt portion comprises segmented sections separated by gaps. 38. The vial adapter according to claim 37, wherein the segmented sections comprise inwardly projecting undercuts. 39. The vial adapter according to claim 35, wherein the access member is a needle-free valve. 40. The vial adapter according to claim 39, wherein the needle-free valve comprises a female opening securable to a male connector such that two-way fluid communication is provided through the access member. 41. The vial adapter according to claim 39, wherein the needle-free valve is self-sealing. 42. The vial adapter according to claim 35, further comprising a needle-free valve secured with the access member of the housing. 43. The vial adapter according to claim 35, further comprising first supporting rib members extending from the bottom surface of the upper housing section. 44. The vial adapter according to claim 35, further comprising second supporting rib members extending from the top surface of the lower housing section. 45. The vial adapter according to claim 35, further comprising first supporting rib members extending from the bottom surface of the upper housing section and second supporting rib members extending from the top surface of the lower housing section. 46. The vial adapter according to claim 43, wherein the first supporting rib members are in sealed relationship with the filter. 47. The vial adapter according to claim 45, wherein the filter is supported between the first and second supporting rib members. 48. The vial adapter according to claim 35, further comprising a finger gripping member projecting from the top surface of the upper housing section. 49. The vial adapter according to claim 35, wherein the expandable chamber is bell-shaped. 50. The vial adapter according to claim 43, wherein the flexible member is peripherally sealed around the bell-shaped expandable chamber. 51. The vial adapter according to claim 35, wherein the filter is a hydrophobic filter. 52. The vial adapter according to claim 35, wherein the expandable chamber is expandable such as to contain at least a portion of a fluid volume equivalent to that introduced through the access member. 53. The vial adapter according to claim 35, wherein the expandable chamber is at ambient pressure in the expanded position. 54. The vial adapter according to claim 35, wherein the expandable chamber is at greater than ambient pressure in an expanded position. 55. The vial adapter according to claim 35, wherein the first and second check valves are spiral check valves, ball check valves, duck-bill check valves, swing check valves or combinations thereof. 56. The vial adapter according to claim 55, wherein at the first check valve and second check valve are spiral check valves. 57. The vial adapter according to claim 35, wherein at the first check valve is positioned between the opening and the internal passage. 58. The vial adapter according to claim 35, wherein at the second check valve is positioned between the expandable chamber and the internal passage. 59. The vial adapter according to claim 35, wherein at the first check valve and second check valve are orthogonal to each other. 60. The vial adapter according to claim 35, wherein the first and/or second check valve restricts leakage at less than 2 psi. 61. The vial adapter according to claim 35, wherein the spike is plastic. 62. A method of reconstituting and/or withdrawing hazardous material comprising: providing a drug container comprising hazardous material; securing a vial adapter as defined in claim 1 to the drug container; and reconstituting and/or withdrawing hazardous material of the drug container via the access member of the vial adapter such that positively displaced volume is one-way communicated to the expandable chamber and/or venting of the drug container is one-way communicated through the opening to the drug container.